The EU Clinical Trials Register currently displays
33931
clinical trials with a EudraCT protocol, of which
5497
are clinical trials conducted with subjects less than 18 years old.
The register also displays information on
18700
older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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The primary objective of this study is to determine the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLT) of BAL101553 administered intravenously as single agent on days 1, 8 and 15 of an every 28 day treatment cycle in adults with advanced or recurrent solid tumors, who have failed standard therapy or for whom no effective standard therapy is available

E.2.2

Secondary objectives of the trial

Secondary objectives are:
•To evaluate the safety and tolerability of BAL101553.
•To evaluate BAL101553 and BAL27862 pharmacokinetics.
•To assess the anti-tumor activity of BAL101553 in cancer patients.
Exploratory objectives are to assess the use of biomarkers and functional imaging to characterize pharmacodynamic effects and to explore the potential utility of biomarkers in blood and/or tumor tissue for patient stratification; and to assess SNP analysis related to drug-metabolism of BAL101553/BAL27862.

E.2.3

Trial contains a sub-study

No

E.3

Principal inclusion criteria

1. Age 18 years or older
2. Patients with one of the following advanced or recurrent solid tumor types, who failed standard therapy or for whom no effective standard therapy is available
a. Colorectal cancer
b.Gastric cancer or cancers of the gastro-oesophageal junction
c.Non-small cell lung cancer
d. Ovarian (or primary peritoneal) cancer
e. Pancreatic cancer (including ampullary cancer)
f. Triple-negative breast cancer
3.Patients with known brain metastases must have stable disease for at least 3 months prior to starting study drug. For these patients imaging of the brain is required during the 14-day screening period; patients must have undergone definitive local therapy (resection and/or radiation).
Measurable disease (according to RECIST criteria v1.1 or RANO criteria for high-grade glioma) or non-measurable prostate or ovarian cancer that can be followed by PSA or CA-125
4. Life expectancy ≥ 12 weeks
5. Acceptable organ and marrow function
6. ECOG performance status ≤ 2
7. Signed, written informed consent must be obtained and documented according to ICH-GCP
8. Other protocol-defined inclusion criteria apply.

E.4

Principal exclusion criteria

1. Patients who have received chemotherapy, radiotherapy, immunotherapy, or investigational agents within 4 weeks prior to starting study drug or who have not recovered to ≤ CTCAE v4 grade 1 from all side effects of prior therapies except for residual toxicities, such as alopecia, which do not pose an ongoing medical risk
2. Symptomatic brain metastases (including leptomeningeal disease) indicative of active disease
3. Peripheral neuropathy ≥ CTCAE v4 grade 2
Known human immunodeficiency virus (HIV) infection
4. Significant cardiac disease or abnormality
5. Uncontrolled intercurrent illness that would unduly increase the risk of toxicity or limit compliance with study requirements in the opinion of the investigator; including but not limited to: ongoing or active symptomatic infection, uncontrolled diabetes mellitus, unstable or uncompensated cardiac, hepatic, renal, respiratory, or
psychiatric illness
6. Current treatment with warfarin potassium or other coumarin derivates.
7. Women who are pregnant or breast-feeding. Men or women of reproductive potential who are not willing to apply effective birth control during the study and for at least 30 days after the last dose of study drug in both sexes
8. Other protocol-defined exclusion criteria apply.

E.5 End points

E.5.1

Primary end point(s)

The primary objective of this study is to determine the maximum tolerated dose (MTD) and to characterize dose-limiting toxicities (DLT) of BAL101553 administered intravenously as single agent on days 1, 8 and 15 of an every 28 day treatment cycle in adults with advanced or recurrent solid tumors, who have failed standard therapy or for whom no effective standard therapy is available.

E.5.1.1

Timepoint(s) of evaluation of this end point

The MTD is determined by DLT assessment. A DLT can occur on any dosing day or at any time thereafter.

E.5.2

Secondary end point(s)

Safety and tolerability, pharmacokinetics, anti-tumor activity

E.5.2.1

Timepoint(s) of evaluation of this end point

Safety and tolerability is assessed during the whole clinical trial.
Pharmacokinetic is assessed at prespecified time points at day 1, day 8 and day 15 during cycle 1 and cylce 2.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

No

E.6.2

Prophylaxis

No

E.6.3

Therapy

No

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

No

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

No

E.6.11

Pharmacogenomic

No

E.6.12

Pharmacoeconomic

No

E.6.13

Others

No

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

Yes

E.7.1.1

First administration to humans

Yes

E.7.1.2

Bioequivalence study

No

E.7.1.3

Other

No

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

No

E.7.4

Therapeutic use (Phase IV)

No

E.8 Design of the trial

E.8.1

Controlled

No

E.8.1.1

Randomised

No

E.8.1.2

Open

No

E.8.1.3

Single blind

No

E.8.1.4

Double blind

No

E.8.1.5

Parallel group

No

E.8.1.6

Cross over

No

E.8.1.7

Other

No

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Information not present in EudraCT

E.8.2.2

Placebo

Information not present in EudraCT

E.8.2.3

Other

Information not present in EudraCT

E.8.3

The trial involves single site in the Member State concerned

No

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

4

E.8.5

The trial involves multiple Member States

No

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

No

E.8.6.2

Trial being conducted completely outside of the EEA

No

E.8.7

Trial has a data monitoring committee

No

E.8.8

Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial

Please see protocol section 3.3.6

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

2

E.8.9.1

In the Member State concerned months

0

E.8.9.1

In the Member State concerned days

0

E.8.9.2

In all countries concerned by the trial years

2

E.8.9.2

In all countries concerned by the trial months

0

E.8.9.2

In all countries concerned by the trial days

0

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

No

F.1.1.1

In Utero

No

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

No

F.1.1.3

Newborns (0-27 days)

No

F.1.1.4

Infants and toddlers (28 days-23 months)

No

F.1.1.5

Children (2-11years)

No

F.1.1.6

Adolescents (12-17 years)

No

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

35

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

13

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

No

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

No

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

No

F.3.3.4

Nursing women

No

F.3.3.5

Emergency situation

No

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

For patients not qualified or incapable of giving legal consent, written consent must be obtained from the legally acceptable representative.

F.3.3.7

Others

No

F.4 Planned number of subjects to be included

F.4.1

In the member state

48

F.5

Plans for treatment or care after the subject has ended the participation in the trial
(if it is different from the expected normal treatment of that condition)

Standard hospital care

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned